17 days ago
- Lead all regulatory activities according FDA and ICH requirements
- Develop global regulatory plans and strategies that support investigational and marketed products and implement strategies for the execution of submissions to regulatory authorities for all phases of the product life cycle.
- Provide expert analysis and evaluation of regulatory information.
- Analyze and make recommendations for improving internal and vendor compliance with the FDA and international regulatory authorities as well as ICH quality regulations and guidelines.
- Communicate with US and other international regulatory agencies and ensures the company is compliant with US and international regulatory requirements
- Prepare/oversee the preparation of meeting requests, briefing documents, coordinate and prepare team for meetings, and interface with regulatory authorities, be primary liaison with regulatory authorities for day-to-day interactions.
- Coordinate and prepare responses to requests for information from regulatory authorities
- Develop and manage a global budget supporting regulatory department
- Hire, mentor, and support the personal and professional development of regulatory staff
- Advanced degree preferred with 10 years of pharmaceutical and drug development regulatory experience
- Previous experience working with the FDA, EMA, and other international regulatory authorities.
- Track record of successful interactions with regulatory authorities, NDA and MAA experience, IND and CTA experience with small molecules.
- Experience developing early and late-phase oncology products
- Knowledgeable of US, EU and international regulatory affairs, GXP compliance and associated regulations.
- Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
- Experience with investigational, including late stage development and marketed products.